Spots Global Cancer Trial Database for A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)
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Trial Identification
Brief Title: A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)
Official Title: A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)
Study ID: NCT05629585
Conditions
Study Description
Brief Summary: This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.
Detailed Description: The study will investigate the efficacy and safety of Dato-DXd with or without durvalumab when compared with ICT (capecitabine and/or pembrolizumab) in participants with stage I to III TNBC who have residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy. The primary objective of the study is to demonstrate superiority of Dato-DXd in combination with durvalumab relative to ICT by assessment of iDFS in participants with stage I to III TNBC with residual invasive disease at surgical resection following neoadjuvant therapy.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Anchorage, Alaska, United States
Research Site, Gilbert, Arizona, United States
Research Site, Tempe, Arizona, United States
Research Site, Tucson, Arizona, United States
Research Site, Tucson, Arizona, United States
Research Site, Hot Springs National Park, Arkansas, United States
Research Site, Little Rock, Arkansas, United States
Research Site, Springdale, Arkansas, United States
Research Site, Beverly Hills, California, United States
Research Site, Costa Mesa, California, United States
Research Site, Duarte, California, United States
Research Site, Fountain Valley, California, United States
Research Site, Fullerton, California, United States
Research Site, Harbor City, California, United States
Research Site, Irvine, California, United States
Research Site, La Jolla, California, United States
Research Site, Laguna Hills, California, United States
Research Site, Lakewood, California, United States
Research Site, Loma Linda, California, United States
Research Site, Long Beach, California, United States
Research Site, Los Angeles, California, United States
Research Site, Los Angeles, California, United States
Research Site, Los Angeles, California, United States
Research Site, Newport Beach, California, United States
Research Site, Newport Beach, California, United States
Research Site, Oakland, California, United States
Research Site, Orange, California, United States
Research Site, Orange, California, United States
Research Site, Roseville, California, United States
Research Site, Sacramento, California, United States
Research Site, San Francisco, California, United States
Research Site, Santa Clara, California, United States
Research Site, Sunnyvale, California, United States
Research Site, Torrance, California, United States
Research Site, Upland, California, United States
Research Site, Vallejo, California, United States
Research Site, Walnut Creek, California, United States
Research Site, West Hollywood, California, United States
Research Site, Whittier, California, United States
Research Site, Aurora, Colorado, United States
Research Site, Denver, Colorado, United States
Research Site, New Haven, Connecticut, United States
Research Site, Newark, Delaware, United States
Research Site, Washington, District of Columbia, United States
Research Site, Altamonte Springs, Florida, United States
Research Site, Fort Myers, Florida, United States
Research Site, Hollywood, Florida, United States
Research Site, Miami Beach, Florida, United States
Research Site, Orlando, Florida, United States
Research Site, Palm Bay, Florida, United States
Research Site, Saint Petersburg, Florida, United States
Research Site, Tallahassee, Florida, United States
Research Site, West Palm Beach, Florida, United States
Research Site, Athens, Georgia, United States
Research Site, Atlanta, Georgia, United States
Research Site, Atlanta, Georgia, United States
Research Site, Marietta, Georgia, United States
Research Site, Honolulu, Hawaii, United States
Research Site, Arlington Heights, Illinois, United States
Research Site, Chicago, Illinois, United States
Research Site, Decatur, Illinois, United States
Research Site, Maywood, Illinois, United States
Research Site, Park Ridge, Illinois, United States
Research Site, New Albany, Indiana, United States
Research Site, Des Moines, Iowa, United States
Research Site, Iowa City, Iowa, United States
Research Site, Westwood, Kansas, United States
Research Site, Elizabethtown, Kentucky, United States
Research Site, Lexington, Kentucky, United States
Research Site, Louisville, Kentucky, United States
Research Site, Louisville, Kentucky, United States
Research Site, Louisville, Kentucky, United States
Research Site, Baton Rouge, Louisiana, United States
Research Site, New Orleans, Louisiana, United States
Research Site, Annapolis, Maryland, United States
Research Site, Baltimore, Maryland, United States
Research Site, Baltimore, Maryland, United States
Research Site, Columbia, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, Ann Arbor, Michigan, United States
Research Site, Detroit, Michigan, United States
Research Site, Kansas City, Missouri, United States
Research Site, Saint Louis, Missouri, United States
Research Site, Billings, Montana, United States
Research Site, Omaha, Nebraska, United States
Research Site, Reno, Nevada, United States
Research Site, Camden, New Jersey, United States
Research Site, East Brunswick, New Jersey, United States
Research Site, Hackensack, New Jersey, United States
Research Site, Ridgewood, New Jersey, United States
Research Site, Albuquerque, New Mexico, United States
Research Site, Albuquerque, New Mexico, United States
Research Site, Mount Kisco, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, Rochester, New York, United States
Research Site, Sleepy Hollow, New York, United States
Research Site, Westbury, New York, United States
Research Site, Charlotte, North Carolina, United States
Research Site, Beachwood, Ohio, United States
Research Site, Canton, Ohio, United States
Research Site, Cleveland, Ohio, United States
Research Site, Cleveland, Ohio, United States
Research Site, Cleveland, Ohio, United States
Research Site, Cleveland, Ohio, United States
Research Site, Columbus, Ohio, United States
Research Site, Portland, Oregon, United States
Research Site, Portland, Oregon, United States
Research Site, Allentown, Pennsylvania, United States
Research Site, Harrisburg, Pennsylvania, United States
Research Site, Hershey, Pennsylvania, United States
Research Site, Meadville, Pennsylvania, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, York, Pennsylvania, United States
Research Site, Providence, Rhode Island, United States
Research Site, West Columbia, South Carolina, United States
Research Site, Chattanooga, Tennessee, United States
Research Site, Germantown, Tennessee, United States
Research Site, Knoxville, Tennessee, United States
Research Site, Memphis, Tennessee, United States
Research Site, Nashville, Tennessee, United States
Research Site, Nashville, Tennessee, United States
Research Site, Bedford, Texas, United States
Research Site, Dallas, Texas, United States
Research Site, Dallas, Texas, United States
Research Site, Dallas, Texas, United States
Research Site, Denton, Texas, United States
Research Site, El Paso, Texas, United States
Research Site, Fort Worth, Texas, United States
Research Site, Fort Worth, Texas, United States
Research Site, Houston, Texas, United States
Research Site, Houston, Texas, United States
Research Site, Houston, Texas, United States
Research Site, Lubbock, Texas, United States
Research Site, McAllen, Texas, United States
Research Site, Fairfax, Virginia, United States
Research Site, Gainesville, Virginia, United States
Research Site, Gainesville, Virginia, United States
Research Site, Midlothian, Virginia, United States
Research Site, Norfolk, Virginia, United States
Research Site, Roanoke, Virginia, United States
Research Site, Edmonds, Washington, United States
Research Site, Issaquah, Washington, United States
Research Site, Kennewick, Washington, United States
Research Site, Puyallup, Washington, United States
Research Site, Seattle, Washington, United States
Research Site, Seattle, Washington, United States
Research Site, Spokane Valley, Washington, United States
Research Site, Morgantown, West Virginia, United States
Research Site, Madison, Wisconsin, United States
Research Site, Milwaukee, Wisconsin, United States
Research Site, Anderlecht, , Belgium
Research Site, Brussel, , Belgium
Research Site, Bruxelles, , Belgium
Research Site, Charleroi, , Belgium
Research Site, Edegem, , Belgium
Research Site, Gent, , Belgium
Research Site, Hasselt, , Belgium
Research Site, Liège, , Belgium
Research Site, Namur, , Belgium
Research Site, Sint-Niklaas, , Belgium
Research Site, Wilrijk, , Belgium
Research Site, Brasilia, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Recife, , Brazil
Research Site, Salvador, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, São Paulo, , Brazil
Research Site, São Paulo, , Brazil
Research Site, Vitória, , Brazil
Research Site, North Vancouver, British Columbia, Canada
Research Site, Barrie, Ontario, Canada
Research Site, Kingston, Ontario, Canada
Research Site, Oakville, Ontario, Canada
Research Site, Ottawa, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Laval, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Quebec City, Quebec, Canada
Research Site, Saskatoon, Saskatchewan, Canada
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Bengbu, , China
Research Site, Changchun, , China
Research Site, Changsha, , China
Research Site, Chengdu, , China
Research Site, Chengdu, , China
Research Site, Chongqing, , China
Research Site, Fuzhou, , China
Research Site, Guangzhou, , China
Research Site, Guangzhou, , China
Research Site, Guangzhou, , China
Research Site, Guangzhou, , China
Research Site, Haikou, , China
Research Site, Hangzhou, , China
Research Site, Hangzhou, , China
Research Site, Harbin, , China
Research Site, Hefei, , China
Research Site, Jinan, , China
Research Site, Nanchang, , China
Research Site, Nanjing, , China
Research Site, Nanjing, , China
Research Site, Nanning, , China
Research Site, Qingdao, , China
Research Site, Shanghai, , China
Research Site, Shanghai, , China
Research Site, Shenzhen, , China
Research Site, Shijiazhuang, , China
Research Site, Taiyuan, , China
Research Site, Tianjin, , China
Research Site, Wuhan, , China
Research Site, Wuhan, , China
Research Site, Xi'an, , China
Research Site, Xiamen, , China
Research Site, Zhengzhou, , China
Research Site, Aalborg, , Denmark
Research Site, Copenhagen, , Denmark
Research Site, Herlev, , Denmark
Research Site, Herning, , Denmark
Research Site, Næstved, , Denmark
Research Site, Odense C, , Denmark
Research Site, Sønderborg, , Denmark
Research Site, Vejle, , Denmark
Research Site, Angers Cedex 02, , France
Research Site, Bordeaux, , France
Research Site, Dijon, , France
Research Site, Epagny Metz-Tessy, , France
Research Site, Lyon, , France
Research Site, Montpellier, , France
Research Site, Nimes, , France
Research Site, Paris Cedex 05, , France
Research Site, Poitiers, , France
Research Site, Rennes, , France
Research Site, Saint Herblain Cedex, , France
Research Site, Vandoeuvre Les Nancy, , France
Research Site, Villejuif Cedex, , France
Research Site, Augsburg, , Germany
Research Site, Berlin, , Germany
Research Site, Frankfurt am Main, , Germany
Research Site, Hamburg, , Germany
Research Site, Hannover, , Germany
Research Site, Heilbronn, , Germany
Research Site, Kiel, , Germany
Research Site, Langen, , Germany
Research Site, Leipzig, , Germany
Research Site, Ludwigsburg, , Germany
Research Site, Mönchengladbach, , Germany
Research Site, München, , Germany
Research Site, Paderborn, , Germany
Research Site, Regensburg, , Germany
Research Site, Stuttgart, , Germany
Research Site, Troisdorf, , Germany
Research Site, Tübingen, , Germany
Research Site, Witten, , Germany
Research Site, Wuppertal, , Germany
Research Site, Athens, , Greece
Research Site, Athens, , Greece
Research Site, Athens, , Greece
Research Site, Athens, , Greece
Research Site, Athens, , Greece
Research Site, Heraklion, , Greece
Research Site, Patras, , Greece
Research Site, Thessaloniki, , Greece
Research Site, Thessaloniki, , Greece
Research Site, Bologna, , Italy
Research Site, Brescia, , Italy
Research Site, Firenze, , Italy
Research Site, Genova, , Italy
Research Site, Livorno, , Italy
Research Site, Meldola, , Italy
Research Site, Messina, , Italy
Research Site, Milano, , Italy
Research Site, Milan, , Italy
Research Site, Napoli, , Italy
Research Site, Padova, , Italy
Research Site, Roma, , Italy
Research Site, Rozzano, , Italy
Research Site, Akashi-shi, , Japan
Research Site, Chiba-shi, , Japan
Research Site, Chuo-ku, , Japan
Research Site, Fukuoka, , Japan
Research Site, Fukushima-shi, , Japan
Research Site, Hiroshima-shi, , Japan
Research Site, Isehara-shi, , Japan
Research Site, Kashiwa, , Japan
Research Site, Kitaadachi-gun, , Japan
Research Site, Koto-ku, , Japan
Research Site, Kyoto-shi, , Japan
Research Site, Matsuyama-shi, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Niigata-shi, , Japan
Research Site, Nishinomiya-shi, , Japan
Research Site, Okayama-shi, , Japan
Research Site, Osaka-shi, , Japan
Research Site, Ota-shi, , Japan
Research Site, Sapporo-shi, , Japan
Research Site, Sendai-shi, , Japan
Research Site, Shinagawa-ku, , Japan
Research Site, Shinjuku-ku, , Japan
Research Site, Tsukuba, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Busan, , Korea, Republic of
Research Site, Daegu, , Korea, Republic of
Research Site, Goyang-si, , Korea, Republic of
Research Site, Seongnam-Si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, San Juan, , Puerto Rico
Research Site, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, Bilbao (Vizcaya), , Spain
Research Site, Elche(Alicante), , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Malaga, , Spain
Research Site, Palma de Mallorca, , Spain
Research Site, Toledo, , Spain
Research Site, Valencia, , Spain
Research Site, Göteborg, , Sweden
Research Site, Jönköping, , Sweden
Research Site, Malmö, , Sweden
Research Site, Stockholm, , Sweden
Research Site, Stockholm, , Sweden
Research Site, Stockholm, , Sweden
Research Site, Sundsvall, , Sweden
Research Site, Uppsala, , Sweden
Research Site, Hsinchu, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Tainan City, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taoyuan, , Taiwan
Research Site, Yung Kang City, , Taiwan
Research Site, Cambridge, , United Kingdom
Research Site, Cardiff, , United Kingdom
Research Site, Derry, , United Kingdom
Research Site, Derry, , United Kingdom
Research Site, Edinburgh, , United Kingdom
Research Site, Greater London, , United Kingdom
Research Site, London, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Newcastle upon Tyne, , United Kingdom
Research Site, Portsmouth, , United Kingdom
Research Site, Surrey, , United Kingdom
Research Site, Taunton, , United Kingdom
Contact Details
Name: Aditya Bardia, MD, MPH
Affiliation: Massachusetts General Hospital
Role: STUDY_CHAIR
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